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EC number: 685-617-9 | CAS number: 1099648-69-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March to 09 April 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. However, the isomers ratio is not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of (2R,4R)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol & (2S,4S)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol
- Molecular formula:
- C11H22O2
- IUPAC Name:
- Reaction mass of (2R,4R)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol & (2S,4S)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol
- Reference substance name:
- Reaction mass of (2S,4R)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol & (2R,4S)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol
- Molecular formula:
- C11H22O2
- IUPAC Name:
- Reaction mass of (2S,4R)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol & (2R,4S)-4-methyl-2-(pentan-3-yl)tetrahydro-2H-pyran-4-ol
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless to pale yellow, limpid/translucent liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Test item was considered at 100% for the study.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle – France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 195-207 g
- Fasting period before study: Food was removed at Day 1 and then redistributed 4 h after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet, ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-24 °C
- Humidity: 42-60 %
- Air changes: at least ten changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 25 March to 09 April 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- TEST SUBSTANCE ADMINISTRATION
- Test substance was administered by gavage under a volume of 2.06 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.
MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- yes
- Remarks:
- control animals received distilled water at 2 mL/kg bw
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Observations and a mortality report were then carried out every day for 14 days. Animals were weighed on Day 0 (just before administering the test item) then on Days 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels, then animals were subjected to macroscopic observations. - Statistics:
- None
Results and discussion
- Preliminary study:
- None
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- It was noted the death of 1 treated rat, 24 hours after the test item administration.
- Clinical signs:
- A decrease of the spontaneous activity (6/6) associated with a bradypnea (3/6), an absence of Preyer’s reflex (2/6), eyes partly or completely closed (2/6) and an absence or a decrease of righting reflex (4/6) was registered during the 1st day of the test. The animals recovered a normal activity the 2nd day of the test.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopical examination of the animal which died during the study revealed the presence of red foci on the corpus and the lungs and a thinning of the forestomach.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. - Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off is 2500 mg/kg bw in female rats. Therefore the test substance is not classified according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and classified in category 5 according to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
It was noted the death of 1 treated rat, 24 hours after the test item administration. A decrease of the spontaneous activity (6/6) associated with a bradypnea (3/6), an absence of Preyer’s reflex (2/6), eyes partly or completely closed (2/6) and an absence or a decrease of righting reflex (4/6) was registered during the 1st day of the test. The animals recovered a normal activity the 2nd day of the test. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animal which died during the study revealed the presence of red foci on the corpus and the lungs and a thinning of the forestomach. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In this study, the oral LD50 for test substance was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off is 2500 mg/kg bw in female rats. Therefore the test substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and classified in category 5 (H303) according to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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